Clinical Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy

• ClinicalTrials.gov Identifier: NCT00900562
• Recruitment Status: Terminated
• First Posted: May 13, 2009
• Results First Posted: October 28, 2021
• Last Update Posted: October 28, 2021
• Sponsor: PharmaMar
• Information provided by (Responsible Party): PharmaMar

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Uterine Cervical Cancer; Endometrial Cancer
• Intervention: Drug: Zalypsis ( PM00104)
• Enrollment: 19

Participant Flow

Recruitment Details

Endometrial Cancer: 12 patients were recruited and treated at 4 sites in the US. Patients participated between 14/08/2009 (first consent signed (CS)) and 22/2/2010 (last CS). The first dose was administered on 26/08/2009 and the last dose on 2/4/2010. Cervical Cancer: 7 patients were recruited and treated at 3 sites in the US. Patients participated in the study between 19/8/2009 (first CS) and 22/12/2010 (last CS). The first dose was administered on 26/10/2009 and the last dose on 10/03/2011

Pre-assignment Details

Arm/Group Title	Endometrial Cancer	Cervical Cancer
Arm/Group Description	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
Period Title: Overall Study
Started	12	7
Completed	0	0
Not Completed	12	7
Reason Not Completed
Progressive disease	9	5
Toxicity	1	0
Death	1	1
Withdrawal by Subject	0	1
Unrelated adverse event	1	0

Baseline Characteristics

Arm/Group Title		Endometrial Cancer	Cervical Cancer	Total
Arm/Group Description		Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Total of all reporting groups
Overall Number of Baseline Participants		12	7	19
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	9 75.0%	7 100.0%	16 84.2%
	>=65 years	3 25.0%	0 0.0%	3 15.8%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	12 participants	7 participants	19 participants
		61.5; (51 to 69)	38; (29 to 62)	59; (29 to 69)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	Female	12 100.0%	7 100.0%	19 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	Caucasian	6 50.0%	4 57.1%	10 52.6%
	Hispanic	3 25.0%	0 0.0%	3 15.8%
	African American	0 0.0%	1 14.3%	1 5.3%
	Black	3 25.0%	1 14.3%	4 21.1%
	Other	0 0.0%	1 14.3%	1 5.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	12 participants	7 participants	19 participants
		12	7	19
Eastern Cooperative Oncology Group Performance Status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	0	5 41.7%	1 14.3%	6 31.6%
	1	7 58.3%	6 85.7%	13 68.4%
		[1] Measure Description: Eastern Cooperative Oncology Group Performance Status, ECOG PS 0 Fully active, able to carry on all pre-disease performance without restriction; Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Dead
Histology; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	Adenocarcinoma	0 0.0%	1 14.3%	1 5.3%
	Adenosquamous	0 0.0%	3 42.9%	3 15.8%
	Clear cell	1 8.3%	0 0.0%	1 5.3%
	Endometrioid	4 33.3%	0 0.0%	4 21.1%
	Mixed	3 25.0%	0 0.0%	3 15.8%
	Other	1 8.3%	1 14.3%	2 10.5%
	Papillary serous	3 25.0%	0 0.0%	3 15.8%
	Squamous cell carcinoma	0 0.0%	2 28.6%	2 10.5%
Extent of disease; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	Metastatic	10 83.3%	7 100.0%	17 89.5%
	Locally advanced	2 16.7%	0 0.0%	2 10.5%
Histology grade [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	Poorly differentiated	10 83.3%	6 85.7%	16 84.2%
	Moderately differentiated	1 8.3%	1 14.3%	2 10.5%
	Unknown	1 8.3%	0 0.0%	1 5.3%
		[1] Measure Description: Low grade or grade I tumors are well-differentiated. This means that the tumor cells are organized and look more like normal tissue. High grade or grade III tumor cells are poorly differentiated. This means that the tumor cells don't look like normal cells. They're disorganized under the microscope and tend to grow and spread faster than grade I tumors. Cancer cells that don't look well-differentiated or poorly differentiated are called moderately differentiated, or grade II.
Sites involved; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
	1	6 50.0%	1 14.3%	7 36.8%
	2	2 16.7%	2 28.6%	4 21.1%
	3	2 16.7%	2 28.6%	4 21.1%
	>3	2 16.7%	2 28.6%	4 21.1%
Time from diagnosis to first infusion; Median (Full Range); Unit of measure: Months
	Number Analyzed	12 participants	7 participants	19 participants
		18.2; (7.5 to 48.8)	10.7; (6.9 to 91.3)	16.6; (6.9 to 91.3)
Time from last progression to first infusion; Median (Full Range); Unit of measure: Months
	Number Analyzed	12 participants	7 participants	19 participants
		0.9; (0.1 to 5.5)	0.8; (0.4 to 6.4)	0.8; (0.1 to 6.4)
Prior Surgery; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
		11 91.7%	6 85.7%	17 89.5%
Prior Systemic anticancer therapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	7 participants	19 participants
		12 100.0%	7 100.0%	19 100.0%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR)
Description	Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.0. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Time Frame	At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years

Outcome Measure Data

Analysis Population Description

Two patients were not evaluable for efficacy: One patient received only one PM00104 infusion in Cycle 1 and had to be withdrawn from the study due to a troponin I increase, which occurred seven days after the first infusion of PM00104 and was considered serious (SAE) and related to PM00104; One patient only received one PM00104 infusion and was withdrawn from the study due to drug-unrelated marantic endocarditis

Arm/Group Title	Endometrial Cancer	Cervical Cancer
Arm/Group Description:	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
Overall Number of Participants Analyzed	10	7
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

2. Secondary Outcome

Title	Best Tumor Response
Description	Best tumor response was defined as the best response achieved during the study according to RECIST v1.0 CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Time Frame	At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years

Outcome Measure Data

Analysis Population Description

Two patients were not evaluable for efficacy: One patient received only one PM00104 infusion in Cycle 1 and had to be withdrawn from the study due to a troponin I increase, which occurred seven days after the first infusion of PM00104 and was considered serious (SAE) and related to PM00104; One patient only received one PM00104 infusion and was withdrawn from the study due to drug-unrelated marantic endocarditis

Arm/Group Title	Endometrial Cancer	Cervical Cancer
Arm/Group Description:	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
Overall Number of Participants Analyzed	10	7
Measure Type: Count of Participants; Unit of Measure: Participants
SD ≥ 4 months	1 10.0%	0 0.0%
PD	9 90.0%	7 100.0%

3. Secondary Outcome

Title	Progression Free Survival
Description	Progression-free survival (PFS) was defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death had not occurred at the time of the analysis, PFS was censored on the date of last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density
Time Frame	From the date of first infusion of study treatment to the date of progression or death, up to 2 years

Outcome Measure Data

Analysis Population Description

Two patients were not evaluable for efficacy: One patient received only one PM00104 infusion in Cycle 1 and had to be withdrawn from the study due to a troponin I increase, which occurred seven days after the first infusion of PM00104 and was considered serious (SAE) and related to PM00104; One patient only received one PM00104 infusion and was withdrawn from the study due to drug-unrelated marantic endocarditis

Arm/Group Title	Endometrial Cancer	Cervical Cancer
Arm/Group Description:	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
Overall Number of Participants Analyzed	10	7
Median (95% Confidence Interval); Unit of Measure: months
	1.8; (1.7 to 2.0)	1.5; (1.5 to 1.8)

4. Secondary Outcome

Title	Progression Free Survival Rate at 4 Months
Description	Progression-free survival rate at 4 months was defined as the percentage of patients who did not progress and were alive at 4 months. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density
Time Frame	At 4 months

Outcome Measure Data

Analysis Population Description

Two patients were not evaluable for efficacy: One patient received only one PM00104 infusion in Cycle 1 and had to be withdrawn from the study due to a troponin I increase, which occurred seven days after the first infusion of PM00104 and was considered serious (SAE) and related to PM00104; One patient only received one PM00104 infusion and was withdrawn from the study due to drug-unrelated marantic endocarditis

Arm/Group Title	Endometrial Cancer	Cervical Cancer
Arm/Group Description:	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
Overall Number of Participants Analyzed	10	7
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	10; (0.0 to 28.6)	0; (0 to 0)

5. Secondary Outcome

Title	Overall Survival
Description	Overall survival (OS) was defined as the time from the date of first infusion of study treatment to the date of death (due to any cause). Patients with no documented death were censored at the last date they were known to be alive
Time Frame	From the date of first infusion to the date of death, up to 2 years

Outcome Measure Data

Analysis Population Description

Two patients were not evaluable for efficacy: One patient received only one PM00104 infusion in Cycle 1 and had to be withdrawn from the study due to a troponin I increase, which occurred seven days after the first infusion of PM00104 and was considered serious (SAE) and related to PM00104; One patient only received one PM00104 infusion and was withdrawn from the study due to drug-unrelated marantic endocarditis

Arm/Group Title	Endometrial Cancer	Cervical Cancer
Arm/Group Description:	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials	Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
Overall Number of Participants Analyzed	10	7
Median (95% Confidence Interval); Unit of Measure: months
	5.5; (4.8 to 11.5)	5.6 [1]; (NA to NA)

[1]

Insufficient number of participants with events

6. Secondary Outcome

Title	PM00104 Plasma PK Parameters (Cmax) at First Infusion
Description	Cmax Maximum plasma concentration, directly determined from the experimental data
Time Frame	0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of first infusion (Day 1)

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	PM00104
Arm/Group Description:	Zalypsis (PM00104): Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: μg/l
	26.47 (11.98)

7. Secondary Outcome

Title	PM00104 Plasma PK Parameters (AUC) at First Infusion
Description	AUC Area under the plasma concentration-time curve from time zero to infinity.
Time Frame	0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of first infusion (Day 1)

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	PM00104
Arm/Group Description:	Zalypsis (PM00104): Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: h*μg/l
	80.88 (37.41)

8. Secondary Outcome

Title	PM00104 Plasma PK Parameters (Cmax) at Second Infusion
Description	Cmax Maximum plasma concentration, directly determined from the experimental data
Time Frame	0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of second infusion (Day 8)

Outcome Measure Data

Analysis Population Description

All treated patients with second infusion

Arm/Group Title	PM00104
Arm/Group Description:	Zalypsis (PM00104): Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion
Overall Number of Participants Analyzed	16
Mean (Standard Deviation); Unit of Measure: μg/l
	35.02 (21.06)

9. Secondary Outcome

Title	PM00104 Plasma PK Parameters (AUC) at Second Infusion
Description	AUC Area under the plasma concentration-time curve from time zero to infinity
Time Frame	0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of second infusion (Day 8)

Outcome Measure Data

Analysis Population Description

All treated patients with Second infusion

Arm/Group Title	PM00104
Arm/Group Description:	Zalypsis (PM00104): Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion
Overall Number of Participants Analyzed	16
Mean (Standard Deviation); Unit of Measure: h*μg/l
	86.55 (40.41)

Adverse Events

Time Frame	From first infusion to study termination, up to 2 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Endometrial Cancer		Cervical Cancer
Arm/Group Description	Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials		Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks. Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials
All-Cause Mortality
	Endometrial Cancer		Cervical Cancer
	Affected / at Risk (%)		Affected / at Risk (%)
Total	9/12 (75.00%)		5/7 (71.43%)
Serious Adverse Events
	Endometrial Cancer		Cervical Cancer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.67%)		3/7 (42.86%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Anaemia * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Cardiac disorders
Endocarditis noninfective * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Gastrointestinal disorders
Diarrhoea * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Nausea * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Vomiting * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Abdominal pain * 1	0/12 (0.00%)	0	1/7 (14.29%)	3
Constipation * 1	0/12 (0.00%)	0	1/7 (14.29%)	2
General disorders
Pyrexia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Infections and infestations
Escherichia bacteraemia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Enterobacter infection * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Pneumonia * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Investigations
Troponin I increased * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Blood creatinine increased * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Metabolism and nutrition disorders
Anorexia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Dehydration * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Hyperkalaemia * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Nervous system disorders
Cerebral ischaemia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Renal and urinary disorders
Hydronephrosis * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Renal failure * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Pleural effusion * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Productive cough * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Vascular disorders
Deep vein thrombosis * 1	2/12 (16.67%)	3	0/7 (0.00%)	0
Hypotension * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
1 Term from vocabulary, MedDRA (10.0); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Endometrial Cancer		Cervical Cancer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/12 (100.00%)		7/7 (100.00%)
Blood and lymphatic system disorders
Anaemia * 1	2/12 (16.67%)	3	4/7 (57.14%)	9
Thrombocytopenia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Cardiac disorders
Cardio-respiratory arrest * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Sinus tachycardia * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Tachycardia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Ventricular tachycardia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Ear and labyrinth disorders
Ear pain * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Tinnitus * 1	2/12 (16.67%)	3	0/7 (0.00%)	0
Eye disorders
Vision blurred * 1	2/12 (16.67%)	3	0/7 (0.00%)	0
Visual disturbance * 1	2/12 (16.67%)	3	1/7 (14.29%)	1
Gastrointestinal disorders
Abdominal distension * 1	2/12 (16.67%)	2	0/7 (0.00%)	0
Abdominal pain * 1	2/12 (16.67%)	3	2/7 (28.57%)	3
Constipation * 1	7/12 (58.33%)	13	5/7 (71.43%)	13
Diarrhoea * 1	5/12 (41.67%)	5	2/7 (28.57%)	2
Dyspepsia * 1	3/12 (25.00%)	3	0/7 (0.00%)	0
Dysphagia * 1	1/12 (8.33%)	2	1/7 (14.29%)	1
Gastritis * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Mouth ulceration * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Nausea * 1	7/12 (58.33%)	16	4/7 (57.14%)	6
Vomiting * 1	3/12 (25.00%)	3	4/7 (57.14%)	6
General disorders
Asthenia * 1	2/12 (16.67%)	4	1/7 (14.29%)	1
Chest pain * 1	2/12 (16.67%)	2	1/7 (14.29%)	1
Chills * 1	3/12 (25.00%)	4	0/7 (0.00%)	0
Fatigue * 1	7/12 (58.33%)	15	6/7 (85.71%)	12
Generalised oedema * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Mucosal inflammation * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Oedema * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Oedema peripheral * 1	2/12 (16.67%)	3	0/7 (0.00%)	0
Pain * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Pyrexia * 1	4/12 (33.33%)	4	0/7 (0.00%)	0
Infections and infestations
Catheter related infection * 1	0/12 (0.00%)	0	2/7 (28.57%)	2
Fungal infection * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Sepsis syndrome * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Urinary tract infection * 1	3/12 (25.00%)	3	2/7 (28.57%)	2
Injury, poisoning and procedural complications
Fall * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Investigations
Alanine aminotransferase increased * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Aspartate aminotransferase increased * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Neutrophil count decreased * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Weight decreased * 1	2/12 (16.67%)	2	0/7 (0.00%)	0
Metabolism and nutrition disorders
Anorexia * 1	5/12 (41.67%)	8	3/7 (42.86%)	5
Decreased appetite * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Dehydration * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Hypercalcaemia * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Hypokalaemia * 1	0/12 (0.00%)	0	2/7 (28.57%)	4
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/12 (16.67%)	2	0/7 (0.00%)	0
Back pain * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Bone pain * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Muscular weakness * 1	0/12 (0.00%)	0	1/7 (14.29%)	3
Myalgia * 1	2/12 (16.67%)	2	0/7 (0.00%)	0
Pain in extremity * 1	0/12 (0.00%)	0	1/7 (14.29%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain * 1	2/12 (16.67%)	5	2/7 (28.57%)	3
Nervous system disorders
Cerebrovascular accident * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Dizziness * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Dysgeusia * 1	1/12 (8.33%)	2	0/7 (0.00%)	0
Headache * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Hypoaesthesia * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Memory impairment * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Neuropathy peripheral * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Paraesthesia * 1	1/12 (8.33%)	2	1/7 (14.29%)	1
Peripheral sensory neuropathy * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Psychiatric disorders
Depression * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Insomnia * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Mental disorder * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Mood altered * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Renal and urinary disorders
Dysuria * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Haematuria * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Pollakiuria * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Urinary retention * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Reproductive system and breast disorders
Vaginal discharge * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Vaginal haemorrhage * 1	1/12 (8.33%)	1	2/7 (28.57%)	4
Respiratory, thoracic and mediastinal disorders
Cough * 1	2/12 (16.67%)	2	0/7 (0.00%)	0
Dyspnoea * 1	5/12 (41.67%)	5	2/7 (28.57%)	2
Epistaxis * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Hiccups * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Pleural effusion * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia * 1	1/12 (8.33%)	1	1/7 (14.29%)	1
Nail disorder * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Night sweats * 1	3/12 (25.00%)	3	1/7 (14.29%)	1
Vascular disorders
Deep vein thrombosis * 1	0/12 (0.00%)	0	1/7 (14.29%)	1
Jugular vein thrombosis * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
Vena cava thrombosis * 1	1/12 (8.33%)	1	0/7 (0.00%)	0
1 Term from vocabulary, MedDRA (10.0); * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.

Results Point of Contact

• Name/Title: Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
• Organization: Pharma Mar S.A.
• Phone: 0034 91846 60 00
• EMail: clinicaltrials@pharmamar.com

• Responsible Party: PharmaMar
• ClinicalTrials.gov Identifier: NCT00900562
• Other Study ID Numbers: PM104-B-001-09
• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Results First Submitted: July 7, 2021
• Results First Posted: October 28, 2021
• Last Update Posted: October 28, 2021